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OpenTrials
Completed

NCT Number: NCT02295228

Hip Arthroplasty and Vitamin D Status

It is essential that serum 25(OH)D changes following surgery be clarified, and the mechanism(s) underpinning these changes be identified. As such, the overarching hypothesis of this study is that elective total hip arthroplasty reduces serum total 25(OH)D.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective total hip arthroplasty for osteoarthritis
  • Age 50+
  • Able and willing to sign informed consent
  • English speaking
  • Willing to not alter vitamin D supplementation use for the duration of this study
  • Willing to utilize sunscreen of SPF-15 or higher when sun exposure for more than 15 minutes is expected

Exclusion criteria

  • Illnesses known to affect inflammatory marker status including, but not limited to, rheumatoid arthritis, systemic lupus erythematosis and mixed connective tissue disease
  • Chronic diseases that could potentially affect DBP status, e.g., chronic kidney disease stage requiring dialysis, nephrotic syndrome and chronic hepatitis,
  • Hip arthritis from causes other than osteoarthritis
  • Treatment with medications with potential to affect vitamin D metabolism, (e.g., phenytoin, phenobarbital, teriparatide or active vitamin D analogues) or to potentially interfere with 25(OH)D measurement by HPLC (atavaquone) within the preceding three months.
  • Treatment with high dose vitamin D supplementation (50,000 IU weekly or more frequently) within the preceding three months. Note; subjects on a stable daily vitamin D dose will be allowed to participate
  • Surgical procedure within the preceding six months
  • Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer

Treatment and study plan

No intervention

Other

There are no interventions. This is an observational trial.

Primary outcomes

  1. Change in total 25(OH)D

    Time frame: Measured at the pre-operative visit on the day of surgery, post-operative visit (on average 1 to 2 days after surgery), and 6 weeks post-operative visit

Secondary outcomes

  1. DBP (vitamin D binding protein) in serum and urine will be evaluated for 25(OH)D degradation after surgical intervention.

    Time frame: Samples are collected at pre-operative visit on the day of surgery, post-operative (on average 1 to 2 days after surgery) and 6 weeks post-operative visits

    We will evaluate if free 25(OH)D varies over the peri-operative time period. We will evaluate whether the total 25(OH)D change is related to reduced serum DBP and/or increased urinary DBP excretion. We will also correlate the change in free 25(OH)D with serum DBP changes.

  2. Effects of hip arthroplasty on vitamin D metabolite levels in the blood.

    Time frame: Samples are collected at pre-operative visit on the day of surgery, post-operative (on average 1 to 2 days after surgery) and 6 weeks post-operative visits

    We will evaluate the acute and chronic effects of hip arthroplasty on vitamin D metabolites, vitamin D pathway constituents, inflammation, oxidative stress and metabolic markers in plasma using mass spectrometric proteomic and metabolomics analysis.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2014
Registry last updated
Jun 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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